Augmenting Single-session Behavioral Activation (BA) With Delta-beta Transcranial Alternating Current Stimulation (tACS) for the Treatment of Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Clinician-rated Depressive Symptoms
研究概览
简要总结
Investigating whether delta-beta cross-frequency transcranial alternating current stimulation can augment the effects of a single session of behavioral activation in participants with major depressive disorder.
详细描述
The purpose of this study is to examine whether concurrent transcranial alternating current stimulation (tACS) augments the effects of a single session behavioral activation (BA) treatment of depression. Following a series of clinical assessments, participants will perform a reward-based decision-making task while electroencephalography (EEG) is collected.
Then, all participants will take part in a single-session 90-minute BA intervention; half of the participants will receive delta-beta tACS during the final 30 minutes of the session and half will receive an active sham stimulation. Participants will return two weeks later for another task-based EEG. Four weeks after the intervention session, they will receive self-report questionnaires via email to complete online.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
This study is designed to be double-blind. This means that the participant and the researchers are unaware of each participant's assignment until the completion of all data collection. This is accomplished using the randomization codes described above. Furthermore, this study utilizes an active sham stimulation. The active sham condition includes brief stimulation, mimicking the skin sensations associated with tACS. In our previously concluded trial, participants in the delta-beta tACS and active sham groups responded similarly to the blinding questionnaire, indicating that our active sham stimulation successfully blinded the participants.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old or order
- •Able to provide informed consent
- •Willing to comply with all study procedures and be available for the duration of the study
- •Speak and understand English
- •DSM-5 diagnosis of major depressive disorder (MDD) as assessed by the MINI
排除标准
- •Participants must not have active suicide intent as determined by the Columbia Suicide Severity Rating Scale (C-SSRS). Active suicide intent will be captured in responses to items 4 and/or 5 on the C-SSRS.
- •Participants must not meet criteria for current severe substance use disorder, anorexia nervosa, or active psychosis as captured by the MINI.
- •Participants may not currently be in psychotherapy and have not received any other psychotherapy and/or stimulation (ECT, TMS) within the last 4 weeks.
- •Any participants taking psychotropic medication must be on a stable dose for at least 4 weeks with no planned dose changes within the next 4 weeks.
- •(for female participants) Participants must not be pregnant or breastfeeding.
- •Participants may not have any medical or neurological illness for which symptom presentation or treatment could interfere with study participation
- •Participants may not have undergone prior brain surgery
- •Participants may not have any brain devices/implants, including cochlear implants and aneurysm clips
- •Participants may not have had brain injury or concussion within the last three months
- •Participants may not have a history of brain injury requiring current treatment
研究组 & 干预措施
Delta-beta tACS
Participants will receive a single session intervention of behavioral activation (BA) psychotherapy. Stimulation will be delivered via the NeuroConn DC-STIMULATOR MC at 1 milliampere (mA) zero-to-peak amplitude at the target electrodes and 2 mA zero to-peak amplitude at the return electrode. The tACS will be delivered using the cross-frequency stimulation waveform delta-beta (3-20Hz).
干预措施: Delta-beta cross-frequency transcranial alternating current stimulation via the NeuroConn DC-STIMULATOR MC (Device)
Delta-beta tACS
Participants will receive a single session intervention of behavioral activation (BA) psychotherapy. Stimulation will be delivered via the NeuroConn DC-STIMULATOR MC at 1 milliampere (mA) zero-to-peak amplitude at the target electrodes and 2 mA zero to-peak amplitude at the return electrode. The tACS will be delivered using the cross-frequency stimulation waveform delta-beta (3-20Hz).
干预措施: Single-session behavioral activation (Behavioral)
Active-sham tACS
Participants will receive a single session intervention of behavioral activation (BA) psychotherapy. The active sham condition includes brief stimulation, mimicking the skin sensations associated with tACS, assisting with blinding the participant's assignment.
干预措施: Single-session behavioral activation (Behavioral)
Active-sham tACS
Participants will receive a single session intervention of behavioral activation (BA) psychotherapy. The active sham condition includes brief stimulation, mimicking the skin sensations associated with tACS, assisting with blinding the participant's assignment.
干预措施: Active sham cross-frequency transcranial alternating current stimulation via the NeuroConn DC-STIMULATOR MC (Device)
结局指标
主要结局
Clinician-rated Depressive Symptoms
时间窗: Baseline, 2 weeks post treatment
Treatment response will be reported for clinician-rated depression symptom scores using the Hamilton Depression Rating Scale (HDRS). Items are scaled either from 0-2 to 0-4, and each item is summed for a total score ranging from 0 to 53 with higher scores indicating greater depression symptoms. Benchmarks suggested at: 0-7 normal; 8-13 mild depression; 14-18 moderate depression; 19-22 severe depression; \>=23 very severe depression.
次要结局
- Phase-amplitude Coupling (PAC) Between Delta-beta Oscillations During Task Performance of the Streamlined Expenditure of Effort for Reward Task (S-EEfRT)(Baseline, 2 weeks post treatment)
- Proportion of Hard Trials Chosen During the S-EEfRT(Baseline, 2 weeks post treatment)